HIV Posterior Cheek Enlargement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01635504
Recruitment Status : Completed
First Posted : July 9, 2012
Results First Posted : June 18, 2015
Last Update Posted : August 28, 2015
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:

Altered contour of the lower face is a frequent complication of human immunodeficiency virus (HIV). HIV facial lipoatrophy or loss of facial fat commonly results from antiretroviral therapy. Posterior cheek enlargement leading to a bulky and widened lower facial contour can also be seen in HIV. These changes can lead to significant cosmetic disfigurement and have an enormous psychosocial impact on patients. They also make individuals vulnerable by making them recognizable as persons living with HIV. Posterior cheek enlargement has not been well characterized. Both the parotid salivary gland and the masseter muscle are located in the posterior cheek region. Although parotid gland enlargement in a common complication of HIV, it is unknown whether enlargement of the masseter muscle also contributes. The investigators plan to study posterior cheek enlargement in HIV positive individuals. The investigators also plan to use botulinum toxin A as a novel treatment to improve the altered lower facial contour seen in HIV. This treatment has already demonstrated efficacy in HIV negative individuals with enlargement of the masseter muscle. Botulinum toxin has also been used safely in the salivary glands in individuals with excessive drooling resulting from neurological disease. In a trial HIV+ patient, the investigators have already demonstrated the efficacy of using botulinum toxin A in the treatment of posterior cheek enlargement, resulting from both parotid and masseter muscle enlargement. The investigators anticipate this study will increase our understanding of posterior cheek enlargement in HIV and lead to the development of a novel treatment for this important complication.

The investigators hypothesize that posterior cheek enlargement in HIV+ patients will in some cases result from both masseter muscle hypertrophy as well as parotid gland enlargement. The investigators also hypothesize that the treatment of posterior cheek enlargement with botulinum toxin A will result in a more aesthetically appealing lower facial contour in HIV+ patients. This has already been demonstrated in a trial HIV+ patient, in which there was a dramatic change in the volume of the masseter muscle and parotid gland 12 weeks after treatment with botulinum toxin A.

Condition or disease Intervention/treatment Phase
HIV Posterior Cheek Enlargement Biological: Botulinum toxin A Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Posterior Cheek Enlargement in HIV: Anatomic Characterization and Treatment With Botulinum Toxin A
Study Start Date : October 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox HIV/AIDS

Arm Intervention/treatment
Experimental: botulinum toxin A Biological: Botulinum toxin A
Botulinum toxin A 50 units per side of the posterior cheek enlargement, injected into the masseter muscle and parotid gland (10 units into 5 points of the posterior cheek enlargement per side, giving a total of 100 units per patient)
Other Name: Botox

Primary Outcome Measures :
  1. Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A [ Time Frame: Baseline and 12 weeks ]
  2. Percentage Change in Volume of the Parotid Gland From Baseline to 12 Weeks After Treatment With Botulinum Toxin A [ Time Frame: Baseline and 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Aged 19 and older
  2. Are HIV positive
  3. Have facial lipoatrophy and a clinically widened lower facial contour

Exclusion Criteria:

  1. Have had previous facial injection of any other products
  2. Have an active infection on the face
  3. Are receiving active treatment with interferon or systemic corticosteroids
  4. Are pregnant or breast-feeding
  5. Have known preexisting renal disease
  6. Have poorly controlled diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01635504

Canada, British Columbia
Carruthers Dermatology Center
Vancouver, British Columbia, Canada, V5Z 4E1
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Alastair Carruthers, MD University of British Columbia

Responsible Party: University of British Columbia Identifier: NCT01635504     History of Changes
Other Study ID Numbers: H12-00990
First Posted: July 9, 2012    Key Record Dates
Results First Posted: June 18, 2015
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by University of British Columbia:
HIV lipoatrophy
masseter hypertrophy
parotid enlargement
botulinum toxin

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents